FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPACITY + BONE CEMENT
K Number: K080873
·
Decision Aug 28, 2008
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
107
Applicant Total
11
Review Days
150
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OPACITY + BONE CEMENT
- K Number
- K080873
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teknimed, S.A.
- Date Received
- March 31, 2008
- Decision Date
- August 28, 2008
- Product Code
- NDN
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NDN), ordered by most recent decision date.
XeliteMed SuperM-Fix Spinal Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
VCFix Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
FDA 510(k)
FDA Class 2
·Orthopedic
XeliteMed VertehighFix High Viscosity Spinal Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
Balloon Inflation System
FDA 510(k)
FDA Class 2
·Orthopedic
V-STRUT® Vertebral Implant
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Teknimed, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K103433 | F20 | Jan 3, 2011 | Substantially Equivalent |
| K090435 | VERTECEM | Dec 21, 2009 | Substantially Equivalent |
| K083005 | NANGEL | Mar 4, 2009 | Substantially Equivalent |
| K062102 | ODONCER | Apr 16, 2007 | Substantially Equivalent |
| K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT | Mar 17, 2006 | Substantially Equivalent |
| K042911 | CEMENTEK LV | Dec 27, 2004 | Substantially Equivalent |
| K041493 | CEMENTEK | Aug 19, 2004 | Substantially Equivalent |
| K040669 | CERAFORM BONE VOID FILLER | May 3, 2004 | Substantially Equivalent |
| K031826 | TRIHA + | Nov 28, 2003 | Substantially Equivalent |
| K032685 | CEMSTOP CEMENT RESTRICTOR | Nov 26, 2003 | Substantially Equivalent |